A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

April 30, 2011

Study Completion Date

October 31, 2012

Conditions
Neutropenia in Breast Cancer
Interventions
DRUG

Filgrastim (Eurofarma)

Filgrastim will be given at the daily dose of 5 µg/kg body weight, subcutaneously. The weight considered will be the actual weight, for patients weighing up to 120 kg.

DRUG

Filgrastim (Granulokine, Amgen)

Granulokine will be given at the daily dose of 5 µg/kg body weight, subcutaneously. The weight considered will be the actual weight, for patients weighing up to 120 kg.

Trial Locations (6)

Unknown

Hospital de Clinicas de Porto Alegre, Porto Alegre

Hospital Nossa Senhora da Conceição, Porto Alegre

CEPHO - Faculdade de Medicina do ABC, Santo André

Casa de Saúde Santa Marcelina, São Paulo

Centro de Referência da Saúde da Mulher, São Paulo

IAVC - Instituto de Cancer Arnaldo Vieira de Carvalho, São Paulo

Sponsors
All Listed Sponsors
lead

Eurofarma Laboratorios S.A.

INDUSTRY